Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Promise Pharmacy, Llc
Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·416 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·3 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·5 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1...
Injectable Drugs·846 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm...
Injectable Drugs·5 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·30 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·93 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·59 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specia...
Injectable Drugs·158 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·341 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·1 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·139 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor...
Injectable Drugs·819 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbo...
Injectable Drugs·654 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promi...
Ophthalmic Drugs·2,057 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·8 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·296 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·64 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor,...
Injectable Drugs·25 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·43 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US ...
Ophthalmic Drugs·43 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobal...
Drugs·5 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·252 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg...
Injectable Drugs·158 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·59 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US...
Drugs·7 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm H...
Injectable Drugs·196 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US ...
Ophthalmic Drugs·55 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor...
Injectable Drugs·2,595 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·11 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·704 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N,...
Injectable Drugs·15 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·255 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·288 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·210 affected·Dec 17, 2018
High RiskFDA
Us Pharmaceuticals Inc.
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mu...
Drugs·19,752 affected·Dec 7, 2018
High RiskFDA
Us Pharmaceuticals Inc.
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes...
Topical Drugs·7,020 affected·Dec 7, 2018
High RiskFDA
Us Pharmaceuticals Inc.
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 6...
Topical Drugs·67,848 affected·Dec 7, 2018
High RiskFDA
Spectranetics Corporation
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. ...
Surgical Devices·3 affected·Dec 7, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System ...
Surgical Devices·157 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is i...
Surgical Devices·68 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation Sys...
Surgical Devices·4 affected·Dec 3, 2018
CriticalFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 1...
Injectable Drugs·225 affected·Nov 29, 2018
High RiskFDA
Zimmer Biomet, Inc.
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments ...
Medical Implants·971 affected·Nov 28, 2018
High RiskFDA
Aroa Biosurgery
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived e...
Medical Devices·8,853 affected·Nov 27, 2018
High RiskFDA
American Contract Systems, Inc.
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP...
Cardiac Devices·51,152 affected·Nov 21, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixa...
Medical Devices·50 affected·Nov 20, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization an...
Medical Devices·50 affected·Nov 20, 2018